Pediatric Oncology Clinical Trials

Protocol Title
(ALL) Leukemia
COG AALL1732 A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy
COG AALL2131 An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia
COG AALL2321 A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax
(ALL) Leukemia Relapse
COG AALL1821 A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC # 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged ? 1 to < 31 Years Old with First Relapse
COG AALL2121 A Phase 2 Study of SNDX-5613 in Combination with Chemotherapy for Patients with Relapsed or Refractory KMT2A-Rearranged Infant Leukemia (Temp Closed 7/17/25)
(CCL) Cancer Control
COG ACCL1931 A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy
(AML) Myeloid Leukemia
COG AAML1831 A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations
(CNS) Central Nervous System
COG ACNS1833 A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
COG ACNS2031 A phase 3 Study of Sodium Thiosulfate for reduction of cisplatin-induced Ototoxicity in children with average risk medulloblastoma and reduced therapy in children with Medulloblastoma with low risk features
COG ACNS2321 A Phase II Trial Evaluating Chemotherapy followed by Response-Based Reduced Radiation Therapy for Patients with Central Nervous System Germinomas
(GCT) Germ Cell
COG AGCT1531 A PHASE 3 STUDY OF ACTIVE SURVEILLANCE FOR LOW RISK AND A RANDOMIZED TRIAL OF CARBOPLATIN VS. CISPLATIN FOR STANDARD RISK PEDIATRIC AND ADULT PATIENTS WITH GERM CELL TUMORS
COG AGCT1532 A randomized phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumors
(HOD) Hodgkins Lymphoma
COG AHOD2131 A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
(LTE) Miscellaneous
COG ALTE22C1 Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)
COG ALTE2321 Walking Juntos: Developing and Testing a Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
COG ALTE2131 Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults with Cancer
COG ANHL2121 A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
COG ALTE24C1 Quality of End-of-Life Care for Children with Cancer: A COG Groupwide Observational Study
(NBL) Neuroblastoma
COG ANBL1531 A PHASE 3 STUDY OF I-METAIODOBENZYLGUANIDINE (I-MIBG) OR CRIZOTINIB ADDED TO INTENSIVE THERAPY FOR CHILDREN WITH NEWLY DIAGNOSED HIGH-RISK NEUROBLASTOMA (NBL)
COG ANBL2131 A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma
(OST) Osteosarcoma
COG AOST2031 A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
COG AOST2032 A Feasibility and Randomized Phase 2/3 Study of the VEGFR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
(REN) Renal tumors
COG AREN1921 Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
COG AREN2231 Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)
(RST) Rare Soft Tissue
COG ARST2032 A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
COG ARST2531 A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) versus VAC/VI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients with Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma
Screening/Biology Banking/Registry Studies
NCORP DCP-001 Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
COG APAL2020SC Pediatric Acute Leukemia PedAL Screening Trial - Developing new therapies for relapsed leukemias
COG APEC14B1 Everychild APEC14B1 - The Project: Everychild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study

Accordion

Breast

HER2-Negative Breast Cancer Clinical Research

Study: AZD5305

Study title:
EvoPAR-Breast01: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer

Patients with diagnosis of HR-positive, HER2-negative advanced breast cancer, BRCA1, BRCA2, or PALB2m positive mutations.

View AZD5305 study details


Study: STML-ELA-0422

Study title:
ELEGANT: Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

About the study:
ER+/ HER2-negative early stage resected invasive breast cancer without evidence of recurrence or distant metastases, considered at high risk of recurrence at initial staging, who have received at least 24 months but not more than 60 months of endocrine therapy. With no history of any prior invasive breast cancer.

View STML-ELA-0422 study details


Study: S2206

Study title:
Phase III Trial Of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone For Adults With MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

About the study:
Patients with diagnosis of stage II or III breast cancer ER/PR +, HER2 negative, treatment naïve. Not locally recurrent breast cancer.

View S2206 study details


Study: CLEE011O12001

Study title:
Adjuvant WIDER: A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer

About the study:
Patients with diagnosis of Stage IIA, IIB, or III, and ER/PR+, HER2-. May have already received any standard neoadjuvant and/or adjuvant ET, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.

View CLEE011O12001 study details


Triple Negative Breast Cancer Clinical Research

Study: A012103

Study title:
OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy.

About the study:
Patients with diagnosis of TNBC with prior T1cN1-2 or T2-4N0-2 disease, no residual invasive disease, post-≥6 cycles of neoadjuvant chemotherapy + pembrolizumab.


Study: GS-US-595-6184

Study title:
Study title: ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63: A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy.

About the study:
Sacituzumab govitecan + pembrolizumab vs. physician’s choice in residual invasive TNBC post-neoadjuvant therapy and surgery.


Breast Cancer Research: DNA, Precision Oncology, Biobanking, and Other Therapies

Study: MCI/FAU Minorities Biobank (Solid tumors)

Study title:
All patients with archived solid tumor tissue or those undergoing diagnostic procedures (such as biopsies) or surgical interventions can participate in the voluntary donation of their specimens.

MCIFAU Biobank: Patients scheduled for biopsy or surgery, and consenting to contribute leftover tissue to the biobank, will provide clinical data including demographics, tumor type, stage, treatment history, molecular characteristics, and survival outcomes.


Study: 25C60

Study title:
Transforming Cancer Care in Florida: Integrative Cancer Survivorship – Synergizing Biomarkers, Clinical Trials, and Education to Prevent Recurrence and Second Cancers On Hold

Survivors of lung, breast, colorectal, or other solid tumor malignancies at high risk for recurrence or second primary cancer. Patients must completed prior therapy within the last 5 years. No radiographic or clinical evidence of active disease over the past 6 months.

Lung

Early-stage Lung Cancer

Study: A081801

Study title:
ALCHEMIST Chemo-IO (ACCIO):
Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC Must be EGFR (-) & ALK (-)

About the study:
Completely resected stage IIA, IIB IIIA or IIIB NSCLC, in the last 30-77 days, EGFR(-), ALK(-), PD-L1 tested. Treatment naïve.

View A081801 study details


Study: NRG-LU008

Study title:
Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

About the study:
Patients with non-operable or who refuse surgery, Stage IIB or III, node positive, NSCLC, with documented PD-L1. Patients with AGA mutations at registration are eligible, and can be treated with consolidation systemic therapy. No prior RT. T3-4N0 or T0N1-3 patients not eligible.

View NRG-LU008 study details


Advanced/Metastatic Non-Small Cell Lung Cancer

Study: 61186372NSC2012

Study title:
COPERNICUS:
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

About the study:
Patients with diagnosis of NSCLC with epidermal growth factor receptor mutated (EGFRm) Ex19del or Ex21 L858R substitution.

View 61186372NSC2012 study details


Study: CO45042

Study title:
Krascendo 2:
A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

About the study:
Patient with diagnosis of advanced or metastatic non squamous NSCLC, KRAS G12C positive that is not eligible for curative surgery and/or definitive chemoradiotherapy, treatment naïve in the advanced/metastatic setting. With no known concomitant second oncogenic driver with available targeted treatment.

View CO45042 study details


Study: CA224-1093

Study title:
RELATIVITY1093:
A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%

About the study:
Stage IV or recurrent Non-Small Cell Lung Cancer (Non-Squamous), PD-L1 >1%, No Actionable Mutations, treatment naïve in the metastatic setting.

View CA224-1093 study details


Study: M25-274

Study title:
A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

About the study:
Patients with c-Met overexpressing NSCLC, locally advanced or metastatic. No Adenosquamous or neuroendocrine histology, or sarcomatoid features. No Actionable EGFR mutations (Other AGA are permitted) No prior c-Met treatments or docetaxel.

View M25-274 study details


Study: SWOG - Lung-MAP

Study title:
LUNGMAP:
A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer

About the study:
Phase II/III multi-sub-study trial under a hybrid Master Protocol for Stage IV or recurrent/progressive NSCLC with no curative options.

View SWOG - Lung-MAP study details


Study: S1900G

Study title:
A Randomized Phase II Study of INC280 (Capmatinib) Plus Osimertinib With or Without Ramucirumab in Participants With EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

About the study:
Advanced NSCLC with EGFR and MET alterations, involving local or distant spread.

View S1900G study details


Basket Clinical Trials

Study: BiPAVE-001

Study title:
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors

Part B - Cohort B: NSCLC non-squamous, no prior lines or TKI only
Part B - Cohort C: NSCLC with unresectable metastatic disease or locally advanced disease.
Part B - Cohort F: NSCLC non-squamous, (1+ prior line) Slot request required

About the study:
Diagnosis of solid tumor and metastatic disease or locally advanced disease that is not amenable to local therapy.

View BiPAVE-001 study details


Study: SGNB6A-001

Study title:
A phase 1 study of SGN-B6A, an antibody-drug conjugate targeting integrin beta-6, in patients with advanced solid tumors (SGNB6A-001)

Part D - D2: 1L NSCLC PD-1 Naive (TPS <1%): SV + Pembro Slot request required

About the study:
Stage IV Non-Small Cell Lung cancer, no Large cell neuroendocrine tumors nor Small Cell Elements. D1/D2: TPS tested, EGFR (-), ALK (-), treatment naïve for locally advanced or metastatic setting D3: EGFR (-), ALK (-), treatment naïve, for locally advanced or metastatic setting, eligible for carboplatin treatment.

View SGNB6A-001 study details


Study: VMO-01C

Study title:
An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma. With documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor.

(iii) Lung
(iv) Mesothelioma
(vi) any NTRK1+ tumors

About the study:
Patient with a solid tumor malignancy, not responsive to SOC or had progressed following SOC and for which there is no approved or curative therapy. TrkA protein overexpression OR (ii). with documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor.

View VMO-01C study details


Study: 25C60

Transforming Cancer Care in Florida: Integrative Cancer Survivorship – Synergizing Biomarkers, Clinical Trials, and Education to Prevent Recurrence and Second Cancers
On Hold

About the study:
Survivors of lung, breast, colorectal, or other solid tumor malignancies at high risk for recurrence or second primary cancer. Patients must completed prior therapy within the last 5 years. No radiographic or clinical evidence of active disease over the past 6 months.


Study: MCI/FAU Minorities Biobank (Solid tumors)

All patients with archived solid tumor tissue or those undergoing diagnostic procedures (such as biopsies) or surgical interventions can participate in the voluntary donation of their specimens.

MCIFAU Biobank: Patients scheduled for biopsy or surgery, and consenting to contribute leftover tissue to the biobank, will provide clinical data including demographics, tumor type, stage, treatment history, molecular characteristics, and survival outcomes.

Gastrointestinal (GI)

Pancreatic Cancer

Study: PanCan Screening

Study title:
A Registry for Pancreatic Cancer Screening in Patients with Known Genetic Mutations or Familial History

About the study:
High-risk pancreatic cancer cohort: ≥2 first-degree relatives with pancreatic cancer, OR pathogenic mutations (STK11, CDKN2A, Lynch, BRCA1/2, PALB2, ATM) with ≥1 affected first-degree relative, OR Peutz-Jeghers Syndrome (PJS) regardless of family history.


Study: S2433

Study title:
Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

About the study:
Patients with diagnosis of unresectable and/or metastatic ductal adenocarcinoma of the pancreas KRAS and BRAF V600E wild type. No mutations in PTEN, NRAS, EGFR extracellular domain exons 1-16, no amplifications of HER2 and MET, and no gene fusions of RET, NTRK1, and ALK. Must have received only one line of prior systemic cytotoxic chemotherapy. No previous targeted therapy.

View S2433 study details


Gastric Cancer

Study: A022102

Study title:
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma

About the study:
Patients with unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma, with documented PD-L1 CPS.Treatment naïve for unresectable or metastatic disease.

View A022102 study details


Basket Clinical Trials

Study: VMO-01C

Study title:
An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma. With documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor.

(ii) Esophageal regardless TrkA percentage
(v) Pancreatic cancers regardless TrkA percentage
(vi) any NTRK1+ tumors

About the study:
Patient with a solid tumor malignancy, not responsive to SOC or had progressed following SOC and for which there is no approved or curative therapy. TrkA protein overexpression OR (ii). with documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor.

View VMO-01C study details


Study: BiPAVE-001

Study title:
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors

Part B - Cohort E: CRC (1-2 prior lines)

Slot request required

About the study:
Diagnosis of solid tumor and metastatic disease or locally advanced disease that is not amenable to local therapy

View BiPAVE-001 study details


Study: MCI/FAU Minorities Biobank (Solid tumors)

Study title:
All patients with archived solid tumor tissue or those undergoing diagnostic procedures (such as biopsies) or surgical interventions can participate in the voluntary donation of their specimens.

About the study:
MCIFAU Biobank: Patients scheduled for biopsy or surgery, and consenting to contribute leftover tissue to the biobank, will provide clinical data including demographics, tumor type, stage, treatment history, molecular characteristics, and survival outcomes.


Study: 25C60

Study title:
Transforming Cancer Care in Florida: Integrative Cancer Survivorship – Synergizing Biomarkers, Clinical Trials, and Education to Prevent Recurrence and Second Cancers

On Hold

About the study:
Survivors of colorectal, or other solid tumor malignancies at high risk for recurrence or second primary cancer. Patients must completed prior therapy within the last 5 years. No radiographic or clinical evidence of active disease over the past 6 months

Genitourinary (GU)

Study: A032103

Study title:
MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

About the study:
Patients with diagnosis of muscle-invasive urothelial carcinoma of the urethra, bladder, ureter, or renal pelvis. No evidence of residual disease or metastasis, who underwent radical surgery and lymph node dissection, nephroureterectomy or ureterectomy

View A032103 study details


Study: NRG-GU012

Study title:
SAMURAI: Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial

About the study:
Patient with diagnosis of renal cell carcinoma, Node-positive unresectable or metastatic. Patients must have IMDC intermediate (1-2 factors) or poor risk disease (>= 3 factors).Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen. Primary renal tumor measuring 20 cm or less in anterior to posterior dimension

View NRG-GU012 study details


Study: MK5684-004

Study title:
OMAHA-004:
A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA)

About the study:
Patients with diagnosis of metastatic adenocarcinoma of the prostate without small cell histology, who progressed on ADT (or post bilateral orchiectomy), within 6 months, and had prior treatment with PARPi or were deemed ineligible, that have not received a taxane-based chemotherapy for mCRPC or more than one NHA


Basket Clinical Trials

Study: MCI/FAU Minorities Biobank (Solid tumors)

Study title:
All patients with archived solid tumor tissue or those undergoing diagnostic procedures (such as biopsies) or surgical interventions can participate in the voluntary donation of their specimens.

About the study:
MCIFAU Biobank: Patients scheduled for biopsy or surgery, and consenting to contribute leftover tissue to the biobank, will provide clinical data including demographics, tumor type, stage, treatment history, molecular characteristics, and survival outcomes.


Study: 25C60

Study title:
Transforming Cancer Care in Florida: Integrative Cancer Survivorship – Synergizing Biomarkers, Clinical Trials, and Education to Prevent Recurrence and Second Cancers

On Hold

About the study:
Survivors of lung, breast, colorectal, or other solid tumor malignancies at high
risk for recurrence or second primary cancer. Completed prior therapy within the last 5 years. No radiographic or clinical evidence of active disease over the past 6 months


Study: VMO-01C

Study title:
An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma. With documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor.

(vi) any NTRK1+ tumors

About the study:
Patient with a solid tumor malignancy, not responsive to SOC or had progressed following SOC and for which there is no approved or curative therapy. TrkA protein overexpression OR (ii). with documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor.

View VMO-01C study details

Radiation Oncology

CNS

Study: NRG-BN003

Study title:
Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma

About the study:
Patient with diagnosed Unifocal Meningioma newly diagnosed WHO Grade II, gross totally resected, no prior RT.

View NRG-BN003 study details


Lung

Study: NRG-LU008

Study title:
Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

About the study:
Patients with diagnosis of non-operable or who refuse surgery, Stage IIB or III, node positive, NSCLC, with known PD-L1 status prior to registration. Patients with EGFR/ALK/other driver mutation at registration are eligible, and can be treated with consolidation systemic therapy. No prior RT. T3-4N0 or T0N1-3 not eligible.

View NRG-LU008 study details


GU

Study: NRG-GU012

Study title:
SAMURAI:
Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial

About the study:
Patient with diagnosis of renal cell carcinoma, Node-positive unresectable or metastatic. Patients must have IMDC intermediate (1-2 factors) or poor risk disease (>= 3 factors).Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen. Primary renal tumor measuring 20 cm or less in anterior to posterior dimension

View NRG-GU012 study details


GYN

Study: NRG-GY037

Study title:
A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer

About the study:
Newly diagnosed histologically confirmed FIGO (2018) Stage IIIA(T3aN0), IIIB (T3bN0); Stage IIIC1 (T3aN1, T3bN1) IIIC2 (T3aN2, T3bN2); IVA
Squamous cell, adenocarcinoma, adenosquamous cervical cancer.


Basket Clinical Trials

Study: 25C60

Study title:
Transforming Cancer Care in Florida: Integrative Cancer Survivorship – Synergizing Biomarkers, Clinical Trials, and Education to Prevent Recurrence and Second Cancers

On Hold

About the study:
Survivors of lung, breast, colorectal, or other solid tumor malignancies at high risk for recurrence or second primary cancer. Patients must completed prior therapy within the last 5 years. No radiographic or clinical evidence of active disease over the past 6 months.

Basket Trials

Study: MCI/FAU Minorities Biobank (Solid tumors)

Study title:
All patients with archived solid tumor tissue or those undergoing diagnostic procedures (such as biopsies) or surgical interventions can participate in the voluntary donation of their specimens.

About the study:
MCIFAU Biobank: Patients scheduled for biopsy or surgery, and consenting to contribute leftover tissue to the biobank.


Study: 25C60

Study title:
Transforming Cancer Care in Florida: Integrative Cancer Survivorship – Synergizing Biomarkers, Clinical Trials, and Education to Prevent Recurrence and Second Cancers
On Hold

About the study:
Survivors of lung, breast, colorectal, or other solid tumor malignancies at high
risk for recurrence or second primary cancer. Completed prior therapy within the last 5 years. No radiographic or clinical evidence of active disease in the past 6 months.


Study: VMO-01C

Study title:
An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma. With documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor.

(i) Head and Neck Cancers (including squamous cell carcinoma, salivary gland carcinoma and adenoid cystic carcinoma)
(ii) Esophageal, (iii) Lung, (iv) Mesothelioma, (v) Pancreatic cancers, (vi) any NTRK1+ tumors

About the study:
Patient with a solid tumor malignancy, not responsive to SOC or had progressed following SOC and for which there is no approved or curative therapy. TrkA protein overexpression OR (ii). with documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor.

View VMO-01C study details


Study: BiPAVE-001

Study title:
Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors
Part B - Cohort B: NSCLC non-squamous, no prior lines or TKI only
Part B - Cohort C: NSCLC with unresectable metastatic disease or locally advanced disease.
Part B - Cohort E: CRC (1-2 prior lines)
Part B - Cohort F: NSCLC non-squamous, (1+ prior line)
Slot request required

About the study:
Diagnosis of solid tumor and metastatic disease or locally advanced disease that is not amenable to local therapy.

View BiPAVE-001 study details

Hematologic Malignancies & Cellular Therapy

Lymphoproliferative Disorders Clinical Trials

Study: ADCT-402-105

Study title:
LOTIS-7: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.
Slots open loncastuximab tesirine + glofitamab

About the study:
Relapsed/refractory B-NHL, ≥2 prior systemic regimens (dose-escalation) or ≥1 (dose-expansion), requiring systemic treatment.

View ADCT-402-105 study details


Study: SPI-Bel-301

Study title:
CRESCENDO: A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma
Paused for Phase II Part 1 completed 22APR2026

About the study:
Patients with newly diagnosed, untreated histology-proven PTCL based on local pathology review, eligible for treatment with Belinostat, Pralatrexate, and CHOP.

View SPI-Bel-301 study details


Study: MK-1026-010

Study title:
BELLWAVE-010: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax Versus Venetoclax Plus Rituximab in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following at Least 1 Prior Therapy.
Part 2 pending to open July 2026

About the study:
Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease, relapsed/refractory to at least 1 prior therapy.

View MK-1026-010 study details


Study: BGB-11417-302

Study title:
A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

About the study:
Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL)

View BGB-11417-302 study details


Study: A041501

Study title:
A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

About the study:
Newly diagnosed precursor B-cell ALL.

View A041501 study details


Study: S2308

Study title:
Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma

About the study:
Patients with diagnosis of classic follicular lymphoma (cFL) grade 1-3A per WHO-HAEM4R, low-tumor burden follicular lymphoma. Must not have had prior systemic therapy for follicular lymphoma. Radiation therapy for a previous diagnosis of early-stage follicular lymphoma is allowed.

View S2308 study details


Plasma Cell Disorders

Study: 64407564MMY1001

Study title:
MonumenTAL-1 Part 3: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma.
No open slots at the moment.

About the study:
Multiple myeloma with measurable disease, progressed within 6 months or refractory/non-responsive to the most recent therapy. Must have received ≥1 full treatment cycle per line, unless progressive disease was the best response.

View 64407564MMY1001 study details


Study: 64007957MMY3003

Study title:
MajesTEC-4: Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

About the study:
Patient newly diagnosed with Multiple Myeloma, and have received induction +/- consolidation, Must have received only one line of therapy and achieved at least a partial response. Must not have received any maintenance therapy. Should not have received any prior BCMA-directed therapy, or any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy

View 64007957MMY3003 study details


Study: 64007957MMY3005

Study title:
MajesTEC-7: A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

About the study:
Patient newly diagnosed with Multiple Myeloma, and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT). Who have not received any prior therapy for multiple myeloma or smoldering myeloma.

View 64007957MMY3005 study details


Myeloid Diseases

Study: 2215-CL-0203

Study title:
A Phase 1/2, Multicenter, Open-Label, Randomized Dose Ranging and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients With Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive Induction Chemotherapy

No slots available

About the study:
AML (excluding APL) in CR1 (CRp/CRi) with FLT3/ITD mutation in bone marrow or blood. Enrolled <2 months post-final consolidation per local practice. Not proceeding to transplant.

View 2215-CL-0203 study details


Study: NCI-2022-07006

Study title:
MYELOMATCH: Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

About the study:
Patients with previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS. Patients must be treatment naïve.

View NCI-2022-07006 study details


Study: MM1MDS-A01

Study title:
A Randomized Phase II Trial of Enasidenib-Based Therapies Versus Cedazuridine-Decitabine in Higher-Risk IDH2-Mutated Myelodysplastic Syndrome: A MyeloMATCH Sub-Study

About the study:
Patients previously enrolled onto MYELOMATCH screening protocol, and must have been given a treatment assignment to MyeloMATCH to MM1MDS-A01 based on the presence of an actionable mutation.

View MM1MDS-A01 study details


Study: MM1YA-S01

Study title:
A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia

About the study:
Patients previously enrolled onto MYELOMATCH screening protocol, and must have been given a treatment assignment to MyeloMATCH to MM1YA-S01 based on the presence of an actionable mutation.

View MM1YA-S01 study details


Study: MM1YA-CTG01

Study title:
A Measurable Residual Disease (MRD) Driven, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 MYELOMATCH Clinical Trial

About the study:
Patients previously enrolled onto MYELOMATCH screening protocol, and must have been given a treatment assignment to MyeloMATCH to MM1YA-CTG01 based on the presence of an actionable mutation.

View MM1YA-CTG01 study details


Study: MM1OA-S03

Study title:
A Randomized Phase II Trial of ASTX727 and Venetoclax Compared With ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults With IDH2 Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy

About the study:
Patients previously enrolled onto MYELOMATCH screening protocol, and must have been given a treatment assignment to MyeloMATCH to MM1OA-S03 based on the presence of an actionable mutation.

View MM1OA-S03 study details


Cell Therapy Research

Study: INCA34176-357

Study title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

About the study:
New-onset moderate/severe cGVHD, history of allo-HCT from any HLA-matched donor, with ≤1 prior allo-HCT.

View INCA34176-357 study details


Study: 68284528MMY4006

Study title:
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma

About the study:
Serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion.

View 68284528MMY4006 study details


Cell Therapy Research

Study: TSCAN-001

Study title:
A Controlled Multi-Arm Phase 1 Umbrella Study Evaluating the Safety and Feasibility of T-Cell Receptor Engineered Donor T-Cells Targeting HA-1 (TSC-100) or HA-2 (TSC-101) in HLA-A*02:01 Positive Patients Undergoing Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation

About the study:
Patients preparing for allogeneic haploidentical donor transplantation with a diagnosis of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or acute lymphocytic leukemia (ALL), and HLA-A*0201 positive.

View TSCAN-001 study details


Blood and Marrow Transplant

Study: NMDP IRB-1999-0021

Study title:
CIMBTR - Protocol For a Research Database for Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries.

About the study:
Any recipient of unrelated, related donor, or autologous HSC transplant at a CIBMTR center is eligible for the Research Database, including adults (with or without decision-making capacity) and children.

View NMDP IRB-1999-0021 study details


Study: NMDP IRB-1991-0002

Study title:
CIBMTR Sample Repository - Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries.

About the study:
Eligible donors include those who have donated or are scheduled to donate HCs or cellular therapy products for allogeneic recipients via marrow harvest or apheresis (adults and children, with or without decision-making capacity). Patients treated for marrow toxic injury at NMDP RITN centers are also eligible.

View NMDP IRB-1991-0002 study details